Based on the special environment of high-altitude areas and the characteristics of post-disaster medicines demand,this article discussed the difficulties and management strategies for post-earthquake emergency medicines support.Natural conditions such as low temperature,dryness and ultraviolet radiation in high-altitude areas,as well as problems such as weak transportation infrastructure and shortage of medical resources, have posed huge challenges to the stability,transportation,supply,distribution and use of the medicines.Therefore,this paper suggested solutions such as diversified supply channels,transportation reinforcement,temperature and humidity control, light protection measures,sand and corrosion prevention,proposed precautions such as medicine distribution on demand,rational use and strengthening of pharmaceutical care,also emphasized that local cultural habits should be respected.Furthermore, according to high-altitude areas environmental characteristics and different rescue stages (emergency period,sub-emergency period,recovery period),the corresponding emergency medicines catalog was recommended.The study aims to provide scientific basis and practical guidance for the medicine supply of earthquake in plateau, improve rescue efficiency,and reduce disaster losses.
In 2020, the Pharmaceutical Service Committee of the Chinese Pharmaceutical Association, the Respiratory Disease Branch of the Chinese Medical Association, and the Respiratory Physician Branch of the Chinese Medical Doctor Association jointly established the “Cough and Wheezing Pharmaceutical Care Clinic (CWPC) program”.The specification on CWPC construction provides guidance and reference for improving the quality of cough and wheezing pharmaceutical care services.The Chinese Pharmaceutical Association Specifications on Cough and Wheeze Pharmaceutical Care Clinic construction covered two aspects, the construction and service of CWPC, respectively.With the analysis of relevant standards, policies and regulations, technical specifications, literature, and other materials, the specification standardized 19 key elements in the organization's construction, service process, quality management, and evaluation improvement.This paper mainly analyzed the construction process and content of the Chinese Pharmaceutical Association Specifications on Cough and Wheeze Pharmaceutical Care Clinic construction, to strengthen the publicity and implementation of the specification, deepen the understanding of the specification content, and promote the implementation of the specification.
Taste is an important aspect that affects the application and development of oral liquid preparations of traditional Chinese medicine,and bitterness is the main adverse taste of such preparations.In January 2024,the Chinese Society of Traditional Chinese Medicine released the social organization standard "Technical Specification for Sensory Evaluation of Bitterness of Oral Liquid Preparation of Traditional Chinese Medicine" (standard number: T/CACM 1574-2024),led by the Chinese Medicine Preparation Branch of the Chinese Society of Traditional Chinese Medicine,the First Affiliated Hospital of Henan University of Traditional Chinese Medicine,and Beijing University of Traditional Chinese Medicine,with the participation of 22 units nationwide.It provided scientific guidance and good tools for the evaluation of bitterness of such preparations and lays a technical foundation for the subsequent implementation of taste improvement.This article provided a detailed introduction to the background and significance,formulation process,and main content of the standard development,which is beneficial for traditional Chinese medicine pharmacists to understand the standard better,apply,promote,and improve the group's standard,thereby promoting the improvement of the taste quality and patient acceptance of such preparations,and promoting the development of the modernization of traditional Chinese medicine.
Objective To explore the effect of salidroside (Sal) on endoplasmic reticulum stress and connexin 43 in rats with myocardial ischemia-reperfusion injury (MIRI). Methods SD rats were randomly divided into Sham group,MIRI group,low-does Sal (Sal-L) group and high-does Sal (Sal-H) group.The Sham group and MIRI group were intraperitoneal injected with 0.9% sodium chloride solution (10 mL·kg-1·d-1),the Sal-L group and Sal-H group were intraperitoneal injected at a volume of 10 mL·kg-1 with Sal (12,36 mg·kg-1·d-1),respectively.Each group was given a corresponding intervention once a day for 3 d.The MIRI model was established 30 min after the last administration in all groups except the Sham group.The pathological changes of myocardial tissue were observed by Hematoxylin-eosin(HE)staining.TdT-mediated-dUTP nick end labeling (TUNEL) was used to observe the apoptosis of cardiomyocyte,the genes and proteins expression of Cx43 and endoplasmic reticulum stress related factors such as GRP78,Caspase12,CHOP and so on were detected by quantitative real-time polymerase chain reaction (q-PCR) and western blot analysis. Results Compared with the MIRI group,the degree of tissue and cell injury in each Sal group was alleviated,with a decreased apoptosis rate observed in the Sal-H group (P<0.05),the gene expression of Cx43 was up-regulated while GRP78,Caspase12,and CHOP gene expressions were down-regulated in both does groups of Sal.The protein expressions of Cx43 and GRP78 were also be up-regulated and down-regulated respectively in both dose groups of Sal,meanwhile the protein expressions of CHOP,Bax,Caspase12 and cleaved-Caspase3 were down-regulated and the protein expression of Bcl-2 was up-regulated in SAL-H group (P<0.05). Conclusion The protective effect of salidroside on cardiomyocytes may be related to the inhibition of endoplasmic reticulum stress-induced apoptosis and the imbalance of Cx43 metabolism.
Objective To explore the protective effects and mechanism of Shenqi Qiangjing granules containing serum on hydrogen peroxide (H2O2) induced oxidative damage and ferroptosis in mouse spermatogonia (GC-1 spg). Methods Thirty SPF grade healthy male SD rats were selected and randomly divided into blank group,levocarnitine group,and Shenqi Qiangjing granules group.After 7 days of intragastric administration,drug-containing serum was collected from each group.Using mouse spermatogonia as a cell model,they were randomly divided into the normal control group,the model control group,blank serum group,levocarnitine containing serum group,and Shenqi Qiangjing granules containing serum group.Except for the normal control group,the other groups used hydrogen peroxide at a concentration of 600 μmol·L-1 to induce injury to mouse spermatogonia for 4 hours,and then established oxidative stress injury models,after 24 hours of medication intervention in each group.The survival rate of cells was detected using CCK-8 method;The levels of intracellular reactive oxygen species (ROS),malondialdehyde (MDA),catalase (CAT),glutathione (GSH),and superoxide dismutase (SOD) were detected by ELISA;The intracellular iron level was detected by iron ion colorimetry;The activities of Caspase-3 and Caspase-9 were detected by colorimetry;The mRNA levels of glutathione peroxidase 4(GPX4) and ACSL4 were determined by qRT-PCR. Results Compared with the normal control group,the cell proliferation activity of the model control group decreased significantly,the levels of ROS,MDA and Fe3+ were significantly increased,while the activities of CAT,GSH and SOD were significantly decreased in the model control group,however,Caspase-3 and Caspase-9 activities were significantly increased,the results showed significant difference(P<0.05).Compare with the model control group,Shenqi Qiangjing granules containing serum could significantly increase the cell proliferation activity,decrease the levels of ROS,MDA and Fe3+,increase the activities of CAT,GSH and SOD,and decrease the activities of Caspase-3 and Caspase-9,the results showed significant difference(P<0.05).The qRT PCR results showed that compared with the model control group,the expression of GPX4 mRNA was upregulated and ACSL4 mRNA was downregulated in blank serum group containing Shenqi Qiangjing granules,and the differences were statistically significant (P<0.05). Conclusions Shenqi Qiangjing granules have significant protective effects on hydrogen peroxide-induced oxidative stress injury and ferroptosis of spermatogonia in mice.The mechanism may be related to the decrease of Caspase-3 and Caspase-9 activities and the inhibition of oxidative stress injury and ferroptosis.
Objective To explore the mechanism of Huoxin pill(HXP) in the prevention and treatment of heart failure(HF) based on transcriptomics and network pharmacology. Methods The mice were randomly divided into the normal control group, model control group, positive control group treated with sacubitril/valsartan(60 mg·kg-1), low-dose group treated with HXP(31.2 mg·kg-1), and high-dose group treated with HXP(62.4 mg·kg-1).The model control group and each drug treatment group were subcutaneously injected with an equal volume of ISO(5 mg·kg-1) for modeling, while the normal control group was given an equal volume of sterile saline.Six hours later, each drug administration group was gavaged with the corresponding drug for intervention, and the normal control and model control groups were gavaged with an equal volume of sterile water.The modeling and drug administration were continued for 21 days.The cardiac function parameters of the mice were measured using color Doppler ultrasound imaging;ELISA was used to detect the levels of mouse serum cAMP,NT-proBNP,and BNP;HE staining and Masson's trichrome staining were used to evaluate the pathological morphology of cardiac tissue,and the CVF was calculated.Network pharmacology combined with transcriptomics was used to predict potential targets and signaling pathways of HXP in the prevention and treatment of HF,and molecular biology methods were used for validation. Results Compared with the normal control group,the model control group showed an increase in LVESd and LVEDd (P<0.01),and a decrease in LVEF and LVFS (P<0.01);BNP,NT-proBNP,and cAMP levels were increased (P<0.01);myocardial collagen fibers increased and CVF increased (P<0.01).Compared with the model control group,the HXP low-dose group,HXP high-dose group,and positive control groups showed a decrease in LVESd and LVEDd (P<0.01),and an increase in LVEF and LVFS (P<0.01);serum levels of BNP,NT-proBNP,and cAMP decreased (P<0.05);the degree of myocardial fibrosis decreased and CVF decreased (P<0.01).Network pharmacology combined with transcriptomics predicted 10 key targets for HXP in the prevention and treatment of HF: CACNA1H,SCN10A,FGF12,PVALB,ACAN,LGALS3,SERPINE1,MMP3,GSTM1,VDR.Western blot results showed that the protein activation levels of PKA and CREB in myocardial tissue were increased in the model control group compared with the normal control group (P<0.01).Compared with the model control group,HXP low-dose group、HXP high-dose group,and positive control groups showed a decrease in the protein activation levels of PKA and CREB in myocardial tissue (P<0.05). Conclusion HXP has an improvement effect on ISO-induced HF in mice,which may involve numerous targets and the cAMP/PKA signaling pathway.
Objective To determine the material basis of the antioxidant activity of Mori Folium by examining the spectrum-effect relationship. Methods High-performance liquid chromatography (HPLC) was utilized to establish the fingerprints of Mori Folium.The antioxidant activity of Mori Folium was assessed using the 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical scavenging assay and other related indicators.The spectrum-effect relationship of antioxidation was analyzed using gray relational analysis,bivariate correlation analysis,and partial least squares regression analysis.Molecular docking techniques were employed to predict potential interaction targets. Results HPLC fingerprints for 13 batches of Mori Folium were established,and thirteen common peaks were marked,with similarities ranging from 0.932 to 0.998.Nine common peaks were identified by comparing them to reference substances.Differences in antioxidant activity were observed among the different batches of Mori Folium.Based on the analysis of the spectrum-effect relationship,chemical components such as chlorogenic acid,cryptochlorogenic acid,rutin,and isochlorogenic acid B were found to contribute significantly to the antioxidant activity.These components may exert their effects by binding to several antioxidant protein targets,such as XOD,NO-1,and PPAR-α.This implies that Mori Folium might exert its antioxidant action via multiple components and targets. Conclusions By integrating the fingerprint and antioxidant activity of Mori Folium,the contributions of individual components to its antioxidant activity were determined.This study provides an experimental basis for elucidating the substances responsible for the antioxidant activity of Mori Folium and for establishing quality control methods.
To standardize the management of medication errors in medical institutions,the Pharmaceutical Specialized Committee of the Chinese Hospital Association led the formulation of the Pharmacy Management—Adverse Drug Reaction Management—Medication Error Management.The formulation process referred to national regulations,policies,books,and consensus on medication error management.This article described the development process of this standard and provided an in-depth analysis of its key contents.It aimed to guide and inform medical institutions,helping them thoroughly understand and master the requirements for medication error management.The article enhanced the management of medication errors and ensured the safety and effectiveness of medication.
To standardize the management of adverse drug reactions in medical institutions and ensure medicine safety,based on relevant national regulations,normative documents,international and domestic adverse drug reaction management guidelines, and expert opinions,the Chinese Hospital Association Pharmaceutical Specialized Committee led the development of the adverse drug reaction management standard.This article elaborated on the formulation process of this standard and provides an in-depth analysis of its key contents.It aimed to offer guidance and reference for medical personnel,helping them to thoroughly understand and master the management requirements of adverse drug reactions,thereby enhancing the management level of adverse drug reactions and ensuring the safe use of medications for patients.
Prescription evaluation is an important innovative medication supervision mode in China,which is an important means to ensure rational drug use.The Pharmaceutical Specialized Committee of the Chinese Hospital Association had led the formulation of the Pharmacy Administration and Pharmacy Practice in Healthcare Institutions—Part 4-9:Pharmacy Administration—Prescription Evaluation.The standard regulated 11 key elements in the three aspects of basic requirements,evaluation requirements,and quality management and evaluation improvement,which can be used as the basis for guiding medical institutions to standardize prescription evaluation work.This paper introduced the formulation process of the prescription evaluation standard and interpreted the key contents of the standard,which was helpful for peers to deeply understand the standard,promote the implementation of the standard,and further improve the quality of prescription evaluation work.
Clinical pharmacist teacher training is an important mean to improve the quality of clinical pharmacy talent cultivation and ensure the service ability and level of the clinical pharmacist team.The Pharmacy Administration and Pharmacy Practice in Healthcare Institutions-Part 4-8-2: Pharmacy Administration-Pharmacy Training Management-Clinical Pharmacist Teacher Training was based on the newly revised management document for clinical pharmacist teacher training of the Chinese Hospital Association.After sorting out relevant materials,such as standards,policies and regulations,technical specifications,literature,documents of the Chinese Hospital Association,expert opinions,and the current situation of clinical pharmacist teacher training in China,the standard was formulated.In the standard,12 key elements,which can be divided into 3 parts of base management,training process and assessment,quality management and evaluation improvement,were standardized.This article aimed to introduce the construction method and content of the standard,to facilitate the understanding of the standard content for medical institutions which joined or willing to join the clinical pharmacist teacher training base,and to provide a reference for other medical institutions to carry out related work.
Clinical pharmacist training is an important way to strengthen the clinical pharmacist team's construction and improve their pharmaceutical service capabilities and levels.The Pharmacy Administration and Pharmacy Practice in Healthcare Institutions-Part 4-8-1:Pharmacy Administration-Pharmacy Training Management- Clinical Pharmacist Training was based on the relevant requirements of the current clinical pharmacist training system of the Chinese Hospital Association,and formulated by sorting out relevant materials,such as standards,policies and regulations,technical specifications,literature,the current situation of clinical pharmacist training in China,and expert opinions.A total of 15 key elements of clinical pharmacist training were selected and divided into three aspects (base management,training process and assessment,and the quality management,evaluation and improvement).This article mainly introduced the construction method and content of the clinical pharmacist training standard,to deepen the understanding of the standard for relevant units and to promote the implementation of the standard.
To standardize the management of high-alert medications in medical institutions and ensure their safe and effective use, based on relevant national regulations and normative documents,international high-alert medication management guidelines,and expert opinions,the Pharmaceutical Specialized Committee of the Chinese Hospital Association led the development of the Pharmaceutical Supply Services—Key Drugs Management—High-alert Medications.This article elaborated on the formulation process of this standard and provides an in-depth analysis of its key contents.It aimed to offer guidance and reference for medical personnel,helping them to thoroughly understand and master the management requirements of high-alert medications,thereby enhancing the management level of high-alert medications and ensuring the safe and effective use of medications for patients.
Objective By reviewing the access policies for new antimicrobial drugs internationally,this study provides a reference for the development of China's antimicrobial drug access policy. Methods The Chinese and English databases,official websites of health agencies,and health technology assessment agencies of various countries (CNKI,PubMed,NICE in the UK,HAS in France,etc.) were searched to collect and sort out the access policies of new antibacterial drugs.Taking the antibacterial drug ceftazidime-avibactam and the antifungal drug esaconazole sulfate as examples,the key evidence points for the evaluation of antibacterial drugs in the market access process of medical insurance were analyzed.Finally,the author put forward suggestions for China's antibacterial drug access policy based on the opinions of experts in related fields of antibacterial drugs in China. Results Access policies for antimicrobial drugs had already established in the UK,US,EU,Sweden Switzerland,and Republic of Korea.These policies included a series of measures such as evaluation approval rewards,patent extensions,additional reimbursement,decoupling sales revenue from sales volume,etc.,with the ultimate goal being to encourage research and development of new antibiotics while reducing resistance rates.The review found that besides evaluating the safety,economy,and cost-effectiveness,some evaluation agencies also consider the actual clinical value and social value of drugs when reviewing the evidence of two types of new antibacterial drugs in the medical insurance access link. Conclusion China can draw upon international framework principles while considering unique demands such as national antibiotic management policy or national healthcare negotiation requirements to provide certain policy support throughout the market access process for new antimicrobials due to their unique values so that it can encourage research & development while curbing antibiotic resistance.
Objective To evaluate the comprehensive value of methicillin-resistant Staphylococcus aureus (MRSA) treatment drugs in artificial joint infections from multiple perspectives and to solve the problem of MRSA infections in artificial joints. Methods Through literature research,relevant literature was retrieved and clinical studies meeting the requirements were selected and summarized.The Analytic Hierarchy Process (AHP) was applied to collect comprehensive clinical evaluation evidence and to conduct evaluations across different dimensions according to evaluation guidelines;the Delphi method combined with AHP was used for expert anonymous questionnaire evaluation,and the data was compared and analyzed. Results A clinical comprehensive evaluation index model for the treatment of artificial joint infections was successfully established,and the yaahp analysis software was used to score the comprehensive clinical evaluation evidence in various directions.Treatment drugs,vancomycin,daptomycin,and linezolid,at various levels were calculated through the software,and it was concluded that linezolid has the highest clinical comprehensive evaluation score. Conclusion Among the treatment drugs for MRSA infections in artificial joints,linezolid has a higher clinical comprehensive value and can provide a reference for the clinical treatment of MRSA infections in artificial joints.
Objective To investigate the factors affecting the exposure of polymyxin B and the correlation between pharmacokinetic/pharmacodynamic (PK/PD) indexes and efficacy in patients with multidrug-resistant Gram-negative bacterial (MDR-GNB) infections. Methods This prospective study was conducted in patients who received polymyxin B to treat MDR-GNB infections in the intensive care unit of Nanjing Drum Tower Hospital,Medical College,Nanjing University from January 2021 to December 2023.Plasma concentrations of polymyxin B were analyzed using a high-performance liquid chromatography-tandem mass spectrometry,and the influencing factors of exposure were investigated.The predictive value of area under the concentration-time curve (AUC24 h) and AUC24 h to minimum inhibitory concentration ratio for efficacy was determined by the receiver operating characteristic curve. Results The median of AUC24 h was 76.11 (56.06,96.94) μg·mL-1·h in 96 patients with MDR-GNB infections.Patients in the high-dose group (≥150 mg·d-1) were more likely to have higher exposure of polymyxin B than those in the low-dose group (<150 mg·d-1) (P<0.05).The exposure in patients with renal replacement therapy was significantly decreased (P<0.01).However,increasing the dose in patients receiving renal replacement therapy had no significant difference on exposure. The ROC curve showed AUC24 h/MIC was closely correlated with clinical efficacy in patients with MDR-GNB infections (AUCROC=0.724,P<0.01) and the optimal cut-off value of AUC24 h/MIC was 62.1.Subgroup analysis showed that the optimal cut-off values of AUC24 h/MIC in patients with and without pulmonary infection were 70.8 and 61.5,respectively.The clinical efficacy rate was significantly higher in AUC24 h/MIC≥62.1 group,compared with those in AUC24 h/MIC<62.1 group (72.88% vs. 32.43%,P<0.01).After treatment,the decreasing trend of inflammation indicators in AUC24 h/MIC≥62.1 group was superior to those in AUC24 h/MIC<62.1 group. Conclusion The dose and renal replacement therapy are the significant factors influencing the exposure of polymyxin B.AUC24 h/MIC with the target of 62.1 was the optimal exposure index to predict the efficacy in the treatment of MDR-GNB infections and the optimal threshold of AUC24 h/MIC was higher in patients with pulmonary infections than in non-pulmonary patients,so therapeutic drug monitoring is recommended to adjust the AUC24 h/MIC index to achieve individualized medication.
Objective To explore the risk factors of immunoglobulin resistance in children with Kawasaki disease and the effect of different treatments. Methods The clinical data of 1460 children with Kawasaki disease who were diagnosed and treated with IG in Tongji Hospital,Huazhong University of Science and Technology were included.The risk factors of IG resistance in Kawasaki disease were screened by Logistic regression analysis,and the IG resistance groups were divided into 5 groups according to different treatment regimens (group A: once IG+ glucocorticoid, group B: twice IG, group C: twice IG+ glucocorticoid, group D: twice IG+ glucocorticoid + ulinastatin, group E: twice IG+ ulinastatin),and the effects of different drug regimens in IG resistant group were analyzed. Results Multivariate Logistic regression analysis showed that the fever time was ≤ 4 days before the first dose of IG (OR 2.21,P<0.05),monocyte count (OR1.515, P<0.05), lymphocyte count (OR 1.117,P<0.05), RDW-SD (OR1.083,P<0.05), neutrophil ratio (OR 1.07,P<0.05), erythrocyte sedimentation rate (OR 1.02,P<0.05) and serum albumin concentration (OR 0.84,P<0.05) were independent risk factors of IG resistance.There was no significant difference in the rate of coronary artery dilatation,the degree of coronary artery dilatation, and the duration of fever after the first dose of IG in IG resistant groups. Conclusion The fever time ≤ 4 days before the first dose of IG, the increase of monocyte count, the increase of lymphocyte count, the increase of RDW-SD, the increase of neutrophil ratio, the increase of ESR, and the decrease of serum albumin concentration are the independent risk factors of IG resistance.There was no significant difference between the effect of glucocorticoid and ulinastatin on IG resistance in KD and that of IG alone.Glucocorticoid and ulinastatin combined with IG can not benefit patients.
Objective To investigate the bidirectional causal relationship between circulating amino acid levels and the risk of myasthenia gravis (MG) using Mendelian randomization (MR). Methods A two-sample Mendelian randomization analysis was conducted using publicly available genome-wide association study (GWAS) genetic data,with validation from GWAS data from different sources to assess the robustness of the results.Five models were used for the two-sample bidirectional MR analysis,and odds ratios (OR) were calculated to evaluate the causal relationship between the levels of nine circulating amino acids and MG risk.Sensitivity analyses,heterogeneity tests,and pleiotropy tests were performed to assess the robustness of the results.The causal effect estimated by the inverse variance weighted (IVW) method was the primary result,and the IVW-estimated causal effects were further validated using data from different GWAS sources to assess robustness. Results Genetically predicted higher circulating glutamine levels were significantly associated with a lower risk of MG [OR(95%CI)=0.696(0.524,0.926),P=0.012 7,IVW model].Validation analyses using GWAS data from various sources also demonstrated a significant negative association between genetically predicted higher circulating glutamine levels and MG risk [OR(95%CI)=0.321(0.178,0.581),P=1.67×10-1,IVW model].Moreover,genetically predicted higher MG risk was associated with lower levels of circulating glutamine and alanine (β=-0.178 ± 0.009,P=0.049;β=-0.013 ± 0.007,P=0.048,IVW model,respectively). Conclusion Genetic evidence reveals a potential bidirectional causal relationship between circulating amino acid levels and MG risk.Further studies are required to elucidate the mechanisms underlying this relationship.
Prostate cancer is one of the most common male urological malignancies, in which bone metastasis of desmoplasia-resistant prostate cancer is an important stage in the progression of the disease,which seriously affects the quality of life and survival of patients.With the development of nuclide therapy technology in recent years,223-Ra,as a new type of alpha-targeted therapy,has shown good efficacy in the treatment of desmoplasia-resistant prostate cancer bone metastasis.The purpose of this paper is to review the characteristics,mechanism of action,treatment,and the main research results of its treatment of desmoplasia-resistant prostate cancer bone metastasis,and provide a comprehensive review of the clinical application of 223-Ra in the treatment of desmoplasia-resistant prostate cancer bone metastasis for the clinical application of 223-Ra in prostate cancer bone metastasis.
Anticoagulants are widely used in the prevention and treatment of thromboembolism.Existing anticoagulants share the common feature of antagonizing or blocking critical steps in the coagulation cascade,which also increases the risk of bleeding.Studies have indicated that factor Ⅺ inhibitors represent a potential therapeutic option for balancing thrombosis and bleeding risks.In recent years,various factor Ⅺ inhibitors,including antisense oligonucleotides (ASOs),monoclonal antibodies,synthetic small molecules,natural peptides,and aptamers,have been extensively researched as potentially exploitable anticoagulants.Research findings also suggest that factor Ⅺ inhibitors can reduce bleeding risks while ensuring anticoagulant efficacy,exhibiting potential for thrombosis prevention and treatment in patient populations such as those with end-stage renal disease,non-cardioembolic ischemic stroke,and acute coronary syndrome.This article reviewed the mechanisms of action,drug classes,pharmacological characteristics,and clinical research progress of factor Ⅺ inhibitors,aiming to provide insights into the development of new anticoagulants and clinical anticoagulant therapies.
Objective To establish TLC identification method,HPLC fingerprint,chemical pattern recognition,and multi-components quantitative analysis methods of Spatholobus suberectus,and identify the quality of 16 batches of Spatholobus suberectus from different origins. Methods The TLC method was used to identify Spatholobus suberectus qualitatively.HPLC fingerprint of Spatholobus suberectus was established.The quality of Spatholobus suberectus was evaluated by chemical pattern recognition technologies,and the contents of Gallocatechin,protocatechuic acid,catechin,epigallocatechin and fermononetin were determined by HPLC. Results TLC method of Spatholobus suberectus was established.Ten common peaks were identified in 16 batches of Spatholobus suberectus,and 6 components were identified by reference substances.The similarity of fingerprint was 0.769-0.990,indicating good similarity.The samples were divided into 3 groups by cluster analysis.Results of the principal component analysis showed that the top 3 samples in the list of comprehensive scores were S16、S11、S14.Marker compounds that cause the quality difference of Spatholobus suberectus were screened out through the orthogonal partial least squares discriminant analysis,which were fermononetin,peaks 7 and epigallocatechin.Gallocatechin,protocatechuic acid,catechin,epigallocatechin,and fermononetin had a good linearity in the concentration range(r>0.999).The content determination analysis showed that there were significant differences in the contents of the 5 index components among Spatholobus suberectus from different origins. Conclusion The established TLC and HPLC fingerprints of Spatholobus suberectus were stable and reliable,and the HPLC method for multiple active components method provides scientific support for improving the quality control method of Spatholobus suberectus.
Objective To evaluate the cost-effectiveness of inclisiran injection treatment in patients with atherosclerotic heart disease (ASCVD) in China. Methods From the perspective of China's health system,according to the Markov model,patients with ASCVD were divided into inclisilan injection group and placebo group,and both groups were treated with conventional lipid-lowering drugs.The study period was 25 years.The rate parameters,cost parameters,and effectiveness parameters were derived from the ORION-18 trial and other literature.Effects were expressed as quality-adjusted life-years (QALYs).The incremental cost-effectiveness ratio (ICER) was used to evaluate the economy of inclisilan injection.One-way sensitivity analysis and probability sensitivity analysis were used to verify the reliability of the results. Results The treatment effect of the inclisilan injection group was higher (10.02 QALYs),and the cost of the placebo group was lower (255 179 yuan).The ICER of the two groups was 137 850 yuan per QALY gained,and using 257 094 yuan per capita by 2022 as the threshold,the treatment would be economically advantageous.Sensitivity analysis supported this result. Conclusion At present,the additional use of inclisilan injection can get a better treatment effect,and it has economic advantages under the threshold of three times GDP per capita in China.
Objective To summarize a case of latent autoimmune diabetes in adults(LADA)who received medication therapy management (MTM) of pharmaceutical outpatient service,and to provide reference for the treatment of similar diseases. Methods The physician recommended a 61-year-old male patient with LADA to the pharmacy clinic on March 27,2023.The pharmacists provided MTM services for the patient through pharmacy inquiry,medication evaluation,medication reconciliation,medication education,and pharmacy follow-up,return visit or pharmacy follow-up for the patient once a week,and established the patient MTM archives. Results Through fifteen MTM services for over three months,including eight visits to the pharmaceutical outpatient clinic and follow-up seven times.On July 10,2023,the atherosclerotic cardiovascular disease(ASCVD) monitoring indicators,such as fasting plasma glucose (FPG),glycosylated hemoglobin (HbA1c),blood pressure,heart rate,low density lipoprotein cholesterol (LDL-C),and homocysteine (HCY),reduced from 7.17 mmol·L-1,6.8%,140-150/90-100 mmHg,80-90 times·min-1,2.15 mmol·L-1,16.30 μmol·L-1 to 6.06 mmol·L-1,6.1%,120-130/70-80 mmHg,60-70 times ·min-1,1.63 mmol·L-1,8.67 μmol·L-1 after MTM services.The ASCVD monitoring indicators were effectively controlled.After thirty-two weeks,the re-examination of the patient's fasting C-P level remained stable,there was no significant decline in pancreas islet function,and cardiac ultrasound showed that cardiac function had a certain improvement. Conclusion By providing MTM services and reconciliation the medication regimen for the patient with LADA,the ASCVD monitoring indicators such as blood glucose,blood pressure,blood lipids,heart rate,and homocysteine were controlled to meet the standards,effectively protecting the pancreatic β-cell and target organs functions of the patient,and significantly improving his health management level.
The article reported a case of a 40-year-old female patient with unstable angina who was administered indobufen tablets 0.1 g orally twice a day,rosuvastatin calcium tablets 10 mg once daily,and sacubitril/valsartan sodium tablets 100 mg once daily. After one month,she developed severe alopecia and multiple oral ulcers. Considering the association with indobufen,the drug was discontinued,and the patient's symptoms significantly alleviated within a week. The clinical data of the patient and the association with adverse reactions were analyzed and evaluated. It is believed that indobufen causes adverse reactions such as alopecia and oral ulcers.
One patient who underwent mechanical aortic valve replacement was in good condition after surgery, and was discharged with warfarin(2.25 mg·d-1 and 3 mg·d-1 alternatively) and INR 1.91 under the guidance of the pharmacist.After discharge, in addition to taking warfarin and other medication for heart failure treatment, he purchased Huangjing (astragalus) oral liquid at the pharmacy and took it everyday.Twelve days later, he developed recurrent gingival bleeding and INR was 4.95.Warfarin and astragalus oral liquid were stopped immediately, and warfarin was restarted 3 days later.INR was monitored and the dose was adjusted.The maintenance dose of warfarin was 3 mg·d-1 and the INR was around 2.0.It was considered that the abnormally elevated INR was caused by the interaction between warfarin and astragalus extract oral solution.
One fifty years old female patient developed lupus erythematosus with the characteristics of pancytopenia after taking leflunomide 20 mg·d-1 for about 2 months due to rheumatoid arthritis.The symptoms alleviated after the discontinuation of leflunomide and the initiation of symptomatic treatment,which included corticosteroids and other supportive measures.
The patient,male,69-year-old,was given 10mg of dapagliflozin tablets qd for type 2 diabetes mellitus.He developed hemolytic anemia with jaundice about 7 days after oral administration.The occurrence,diagnosis,treatment and follow-up of the adverse drug reactions were retrospectively analyzed.The correlation between dapagliflozin and adverse drug reactions was evaluated,and the possible mechanism of the adverse drug reactions was discussed through literature analysis.This case of adverse drug reactions is rare.We suggested that the monitoring of the adverse reactions of blood system should be strengthened to ensure the safety of clinical use of dapagliflozin.
Objective To evaluate the effectiveness and feasibility of a remote medication treatment management model for elderly patients with chronic disease at home based on mobile technology. Methods A convenient and elderly-friendly mobile application (hereinafter referred to as Yaoshiyi APP) was developed, and a remote medication treatment management team consisting of clinical pharmacists from tertiary hospitals, community pharmacists, and community physicians was formed.Patients from communities were selected for practical research, led by pharmacists.Based on the Yaoshiyi APP, patients were subjected to 6 months of medication treatment management practice, and the effectiveness and feasibility of the practice were evaluated. Results The Yaoshiyi APP can be integrated with a variety of medical-grade wearable devices to realize the functions of automatically uploading monitoring data, abnormal value reminding, medication reminding, medication consultation, and medication science popularization.A total of 302 elderly patients with chronic disease at home completed the study.The results showed that pharmacists have identified and intervened in 695 cases of medication-related problems.According to the classification of medication-related problems, the top three were 247 cases ( 35.5% ) of additional treatment, 97 cases (14.0%) of unnecessary drug treatment, and 93 cases (13.4%) of medication compliance problems.The patient's medication adherence score(Morisky medication adherence scale-8, MMAS-8) increased from (5.85±1.57) at enrollment to (6.74±1.23) 6 months after enrollment (P<0.01).After 6 months of enrollment, the patient's satisfaction with the pharmacist's work reached a score of (4.99±0.08) out of 5.The average reduction in drug costs for patients caused by pharmacists intervening in irrational medication is (20.9±18.0)%. At the end of follow-up, 93.4% of patients were proficient in using the Yaoshiyi APP. Conclusion The remote medication treatment management model for elderly patients with chronic disease at home based on mobile technology constructed in this study can effectively improve patient compliance with disease monitoring and medication, ensure rational drug use, reduce medical resource waste, and receive high patient acceptance.
Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and improvement of drug instructions. Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodialysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with molecular weight≥5 000,or binding rate of plasma protein≥60%,or drug distribution volume>360L were classified as “non-dialysis group”,and other drugs were classified as “dialysis group”,compared the labeling rate of corresponding information of drugs in “dialysis group” and “non-dialysis group”;and compared the labeling rate and content with relevant information in Lexicomp and Micromedex. Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and explicit drug adjustment plan were 16.67%,25.16%,and 24.52%.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the "dialyzable group" and the "non-dialyzable group"(P<0.01).The difference in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P<0.01). Conclusion Attention should be paid to the lack of information and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.
Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the successful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of natriuretic criteria. Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclusion and exclusion criteria in the protocols. Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being <65 years of age (333,78.4%),of which the most important reasons included voluntary withdrawal (71,16.7%),tumor metastasis (52,12.2%),failure to recover from treatment of pre-existing disease (38,8.9%),failure of bone marrow function (19,4.5%),and non-compliant liver function (15,3.5%).Among the nadir indicators,the age of the subjects (100%),ECOG score (97.5%),bone marrow function (ANC:95.0%,PLT:97.5%,HB:97.5%),liver function (T-BiL:95.0%,ALT:87.5%,AST:95.0%),renal function (CR:80.0%),and viral screening (HIV:80.0%,HBV:70.0%,HCV:62.5%) were relatively stringent. Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are closely related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects' characteristics,accurate setting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to provide more relevant information will help to improve the screening success rate of clinical trials.
Objective To construct an evaluation index system for rational drug use management of key monitoring drugs,and to provide references for medical institutions. Methods The preliminary index framework was formed by researching the policies and regulations,management norms,and guiding principles related to key monitoring drugs.Two rounds of Delphi questionnaire survey were conducted with 26 experts to improve and optimize the index system.The weights of the indicators were obtained by constructing the judgment matrix by analytic hierarchy process (AHP). Results The recovery rates of the two rounds of questionnaire were both 100%,and the authority coefficient was 0.87.The key monitoring drug rational use management evaluation index system was finally constructed to include three primary indicators [ex-ante management(0.253 6),in-process management(0.503 1),and ex-post management(0.243 2)],15 secondary indicators [including prescription review(0.302 6),formulate rational drug use norms(0.133 1),supernormal early warning management(0.103 2)],and 62 tertiary indicators[including formulate strict prescription review rules (0.152 5),pharmacists prescription intervention strength(0.085 7) and effectiveness management(0.052 5)].and the index judgment matrix passed the consistency test. Conclusion The evaluation index system for the rational drug use management of key monitoring drugs constructed can satisfy the closed loop of the supervision and management process,achieve the prior reminder,monitoring,and post-supervision,and provide references for medical institutions to ensure the refinement and standardization of the management process.